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Primary Extranodal LymphomaPhase 2CREDITNCT05093140

Camrelizumab Plus R-CHOP Regimen in Untreated Primary Extranodal DLBCL

A Phase 2 study testing Camrelizumab in people with Primary Extranodal Lymphoma and DLBCL, run by Sun Yat-sen University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To assess the efficacy and safety of camrelizumab combined with rituximab, vincristine, doxorubicin, cyclophosphamide and prednisone in the treatment of untreated primary extranodal DLBCL Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Primary Extranodal Lymphoma, DLBCL
What is being tested?
Camrelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Jun 2022to Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • Male or female patients: 18-65 years old.
  • Newly diagnosed patients
  • Primary extranodal lymphoma, histologically-confirmed DLBCL( including but not limited to follicular lymphoma grade 3B, or transformed DLBCL, EBV(+) DLBCL, ALK(+) DLBCL, high grade lymphoma). The primary site is limited to the gastrointestinal tract, nasal cavity and breast, and central nervous system( CNS) involvement must be excluded. Gastrointestinal tract involvement of DLBCL can be included in the group after evaluation without bleeding or perforation risk.
  • ECOG physical condition score: 0-2 points for patients.
  • The patients must be with at least one evaluable or measurable lesion meeting Lugano 2014 criteria, the evaluable lesion was: 18F fluorodeoxyglucose / positron emission tomography (18FDG-PET) examination showed that the uptake of extranodal areas was increased (higher than that of liver) and pet and / or computed. The features of tomography (CT) were in accordance with lymphoma. The measurable lesions were nodal lesions with a length of > 15 mm or extranodal lesions with a length of > 10 mm, accompanied by an increase in 18-FDG uptake. It is necessary to exclude the case where there is no measurable lesion and the diffuse 18-FDG uptake increase in the liver.
  • Hematology values must be within the following limits at baseline:
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  • Absolute neutrophil count (ANC) ≥1,500 cells/μL. In case bone marrow involvement, ANC≥1,000 cells/μL.
  • Platelets≥75,000 cells/μL. In case bone marrow involvement, platelets≥50,000 cells/μL
  • Hemoglobin≥90 g/L
  • Biochemical values must be within the following limits at baseline:
  • Alanine aminotransferase（ALT）≤3×upper limit of normal (ULN).
  • Aspartate aminotransferase (AST) ≤3×ULN
  • Total bilirubin≤1.5×ULN, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin.
  • Serum creatinine ≤2×ULN or estimated Glomerular Filtration Rate ≥40/mL/min/1.73m2
  • LVEF within institutional normal limits, as determined by echocardiography or multiple uptake gated acquisition (MUGA) scan.
  • Each subject (or their legally acceptable representative) must sigh an informed consent form (ICF) indicating that he or she understands the purpose of any procedures for the study and are willing to participate in the study.
  • Women of childbearing potential ( WOCBP) must have a negative serum (beta-human chorionic gonadotropin[β-hCG] ) or urine pregnancy test within 7 days before the first medication
  • Women of childbearing potential or men and their WOCBP partners should agree to take effective contraceptive measures from signing the ICF to 6 months after the last dose of study medication.

Who cannot join

  • • Primary DLBCL arise in lymph nodes or other lymphatic tissues.
  • Primary central nervous system lymphoma or secondary central nervous system involvement, known primary mediastinal lymphoma.
  • A history of severe allergies or allergic reactions to humanized or murine monoclonal antibodies.
  • In the past five years, patients with other malignant tumors have undergone radical treatment, except for basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of breast and carcinoma in situ of cervix. History of human immunodeficiency virus (HIV) infection and/or patients with acquired immunodeficiency syndrome are known
  • Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA titer (no more than 2500 copies/mL or 1000 IU/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. In addition to active hepatitis B or hepatitis C infections requiring treatment, group trials can be conducted. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 2500 copies/mL or 1000 IU/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group.
  • Patients with any active infections requiring systemic anti-infective treatment within 14 days of treatment.
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  • Received systemic antineoplastic therapy within 28 days before treatment, including chemotherapy, immunotherapy, biotherapy (cancer vaccine, cytokines, or growth factors that control cancer), etc..
  • Received major surgery within 28 days before treatment or radiotherapy within 90 days before treatment.
  • Received live vaccination (except influenza attenuated vaccine) within 28 days before treatment.
  • Patients requiring long-term systemic glucocorticoid therapy or other immunosuppressive therapy (>prednisone 10mg/qd or equivalent dose of other glucocorticoid therapy). Allowing subjects to use local, ocular, intra-articular, intranasal and inhaled glucocorticoid therapy.
  • Patients suffering from uncontrollable comorbid diseases, including but not limited to symptomatic congestive heart failure, uncontrollable hypertension, unstable angina, active peptic ulcer or bleeding disorders.
  • Pregnant or lactating women.
  • Patients with a history of interstitial lung disease or non-infectious pneumonia. Subjects who have previously had drug-induced or radioactive non-infectious pneumonia but asymptomatic are allowed to enroll.
  • Any life-threatening disease, physical condition or organ dysfunction according to the researchers' judgment may endanger the safety of the subject or put the clinical research at excessive risk.

Trial locations and contacts

No sites are listed yet.

Huiqiang Huang, professor contact

0086-13808885154

huang_sysu@163.com

About this study

Official title: Anti-PD-1 Antibody (Camrelizumab) Plus R-CHOP Regimen for the Primary Extranodal Treatment-Naive Diffuse Large B Cell Lymphoma (CREDIT): a Prospective, Multicenter, Single-Arm, Phase II Trial

To assess the efficacy and safety of camrelizumab combined with rituximab, vincristine, doxorubicin, cyclophosphamide and prednisone in the treatment of untreated primary extranodal DLBCL

Being tested
Camrelizumab
Keywords
primary extranodal lymphoma, DLBCL, R-CHOP, PD-1, camrelizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CamrelizumabDrug

    Also called Rituximab, Cyclophosphamide, Hydroxyldaunorubicin, Vincristine

    Induction therapy:

    Camrelizumab 200mg, ivd, D1, Rituximab 375mg/m2, ivd, D1 every 3 weeks up to 2 cycles

    Immunochemotherapy:

    Rituximab: 375mg/m2, ivd, D1; Cyclophosphamide: 750mg/m2, iv or ivd, D1; Hydroxyldaunorubicin: 50mg/m2, iv or ivd, D1; Vincristine: 1.4 mg/m2 , iv(max：2mg), D1; Prednisone: 60mg/m2, po, d1-5 every 3 weeks up to 6 cycles Maintenance therapy: Camrelizumab 200mg, ivd, D1 every 4 weeks up to 6 cycles

Study groups in NCT05093140
Study groupRoleWhat they receive
camrelizumab+R-CHOPExperimentalInduction therapy: camrelizumab in combination with rituximab Immunochemotherapy: rituximab, cyclophosphamide, hydroxyldaunorubicin, vincristine, prednisone Maintenance therapy: camrelizumab in patients achieved CR after immunotherapy
Receives: Drug: Camrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. complete response rate

    Measured: 24 weeks

Secondary outcomes (6)

  1. Objective remission rate

    Measured: six weeks

  2. Objective remission rate

    Measured: 24 weeks

  3. Duration of Response

    The time from the first assessment of CR or PR to PD (progressive disease) or death from any cause

    Measured: 2 years

  4. Progression-free Survival

    PFS was defined as time from study registration to first disease progression or death whichever occurred first, otherwise subject data were censored at time last known disease free

    Measured: 2 years

  5. Overall Survival

    OS was defined as time from study registration to death, and otherwise censored at time last known alive

    Measured: 2 years

  6. Percentage of Participants With Adverse Events (AEs)

    Number of participants with adverse events occurring up to 30 days after the last administration are evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0

    Measured: Up to 30 days after the last cycle of per-protocol treatment and 90 days after last dose of anti-PD-1 antibody

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2021
  2. Study start1 Jun 2022 (estimated)
  3. Primary completionJun 2023 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05093140
Sponsor's protocol ID
MA-DLBCL-Ⅱ-004
Acronym
CREDIT
Status last verified
Apr 2022
First submitted
11 Oct 2021
Last updated
7 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab in people with Primary Extranodal Lymphoma and DLBCL, run by Sun Yat-sen University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Huiqiang Huang, professor (0086-13808885154, huang_sysu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complete response rate (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05093140.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.

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